By: Sam Maddox
Clinical trials are being held, or planned, for several promising therapies for spinal cord injury. The translation of research to application requires a coordinated approach, from preclinical data assessment, trial protocols to actual treatment and outcome measures.
The Journal of Neurosurgery: Spine recently dedicated an entire issue to clinical trial developments in SCI. The single-focus supplement centers on the activities of the Reeve Foundation's North American Clinical Trials Network (NACTN). Proving a therapy effective requires a framework for studying large numbers of patients. That's where NACTN comes in, to provide expertise, infrastructure, and efficiency to run trials and evaluate their results. Funding is from the Reeve Foundation and the Telemedicine & Advanced Technology Research Center, US Army Medical Research and Materiel Command.
NACTN is a consortium of university hospital neurosurgical and neurorehabilitation teams. Said NACTN's lead investigator, neurosurgeon Robert G. Grossman, (Methodist Hospital, Houston), "There can be no progress without partnerships, without collaborations, without alliance-building. Spinal cord injury is too difficult and too expensive to go-it-alone." There are many challenges -- organizational, regulatory, and financial -- that can slow the process of conducting clinical trials. "The multicenter NACTN approach," said Grossman, "will minimize delay."
The journal supplement comprises 17 articles and several editorials. It is an academic collaboration between the journal and AOSpine North America (an international community of spine and orthopedic surgeons, neurosurgeons, academics, and other spine care professionals). The supplement was directed by Michael Fehlings, Professor of Neurosurgery at the University of Toronto and Medical Director of the Krembil Neuroscience Centre at the Toronto Western Hospital.
The 246-page peer-reviewed supplement includes papers related to identifying and evaluating different types of spinal cord trauma, including a characterization of the incidence and severity of acute complications after SCI, based on a large patient database maintained by NACTN. Also, the NACTN decision making process for choosing which therapies to study is evaluated.
A number of reviews summarize evidence for predicting neurological outcome in patients with both cervical and thoracic SCI, identifying gaps in research and making recommendations for future research. The discussion includes the development of newer graded assessments to better define the scope and extent of injury, and of recovery.
The supplement also features original clinical studies and review articles on current and potential drug-based therapies, including the drug Riluzole, which was tested in the first NACTN clinical trial, a Phase I safety study completed last year.